Randomized, double-blind, placebo-controlled, food allergy challenge to olestra snacks

Following approval of the fat replacer olestra for use in preparing savory snacks, Procter & Gamble implemented a postmarketing surveillance program t o monitor marketplace introduction. Three and one-half percent of all healt h effects reported by consumers to the surveillance toll-free number were a llergy-type symptoms (e.g., rash, itching, edema, hives, dyspnea). Because of these reports, we investigated whether olestra or some component of oles tra snacks was a likely allergen in some subset of the population. A single center, randomized, double-blind, placebo-controlled, within-subject cross over food challenge study was conducted to confirm or refute the allergenic ity of olestra snacks. Of the 65 subjects who reported symptoms consistent with immediate hypersensitivity to olestra's postmarketing surveillance pro gram, 14 men and women traveled to the Arkansas Children's Hospital Researc h Institute to participate in this study. Each subject underwent a standard skin prick test at the beginning of the study, to help determine what comp onent, if any, of the olestra product was allergenic. Following the skin pr ick test, subjects ate in random order, olestra-containing potato chips and regular fat-containing potato chips. The dose of potato chips consumed at each challenge was at least the amount alleged to have caused the symptoms that prompted the consumer to phone the postmarketing surveillance toll-fre e number. No subject experienced an allergic reaction after consuming the o lestra-containing chips. Nor did any subject elicit a positive response to olestra following the skin prick testing. Two subjects had positive reactio ns consistent with immediate hypersensitivity after consuming the regular-f at, placebo potato chips. The results of this study confirm that olestra is unlikely to have an allergenic potential. (C) 2001 Academic Press.